Balloon angioplasty catheters have been used to treat cardiovascular disorders for many years. In general, balloon angioplasty catheters of the prior art have included over-the-wire catheters, which ride over a separate guide wire, which represent the majority of balloon catheters, fixed-wire catheters, which combine the balloon catheter and guide wire into one device, and rapid exchange catheters, which are essentially over-the-wire type catheters with short guidewire lumens that allow the catheter to be exchanged without the use of an extension wire.
The fixed wire balloon angioplasty catheters of the prior art have typically ranged in length from about 120 cm to about 150 cm and have had balloon dimensions and flexural properties that were suitable for performing balloon angioplasty procedures in coronary or peripheral blood vessels. Examples of commercially available fixed-wire balloon angioplasty catheters include the Ace™ balloon catheters (Boston Scientific, Inc., Natick, Mass.).
More recently, procedures have been developed wherein balloon catheters are used to dilate the ostia (or other openings) of paranasal sinuses for the treatment of disorders such as sinusitis. In these procedures, a balloon catheter or other dilator catheter is advanced transnasally into an opening of a paranasal sinus and used to dilate that opening, thereby improving drainage and ventilation of the affected sinus. In some embodiments, a guide catheter is initially inserted into the nose, a guidewire is then advanced through the guide catheter and the balloon catheter is then advanced over the guidewire. In other embodiments, as described in parent application U.S. patent application Ser. No. 11/150,847, issued as U.S. Pat. No. 7,803,150, the balloon catheter may be equipped with a non-removable guide member that extends from its distal end and is advanceable through the ostium of the paranasal sinus ahead of the catheter shaft and balloon. The provision of such non-removable guide member extending from the distal end of the balloon catheter eliminates the need for use of a separate guidewire, thereby simplifying the procedure, shortening the procedure time, reducing the need for an assistant, and decreasing the amount of radiation exposure to the patient and operator due to use of fluoroscopy.
There remains a need in the art for further development and refinement of balloon catheters (and other dilator devices) that have non-removable guide members for use in dilating the ostia of paranasal sinuses.